BuPROPion Hydrochloride Extended-Release Tablets recall: Failed Dissolution
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
Why was BuPROPion Hydrochloride Extended-Release Tablets recalled?
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: MR3365, Exp. Feb 17
- Product
- BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Quantity
- 2,472 units
- Distribution
- Nationwide
- Recall date
- November 30, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)